Biotech Clinical Trial Solutions

A personal, responsive and committed biotech CRO

Whether you’re a team of two or a biotech company with more than 100, our dedicated team of Biotech experts will amplify your team's expertise to help you uncover insights faster to impact patient lives.

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From regulatory and commercial strategy to cutting-edge trial design and execution, our team of experts anticipate and adaptively deliver the solutions you need, when you need them.

Every service, at your fingertips

At Parexel Biotech, we combine our established end-to-end operational approach with biotech teams who have the expertise and experience to anticipate and adapt throughout development, mitigating risk at every step. Our talented experts have the knowledge and wisdom of having done it before, collaborating with your team, no matter how big or small, to help you see the unseen solutions and bring life-changing treatments to patients.

Read the transcript

As a biotech company, you’re at the forefront of innovation — dedicated to bringing life-changing treatments to patients.

And at Parexel Biotech, we have the unique expertise to supercharge your clinical development.

We share your passion to change lives, and give you access to a deep, diverse team of world-class experts.

We offer a right-size solution — providing the personal, responsive, and committed approach of a small CRO, with all the benefits of a large CRO.

And as one of the first CROs to establish a dedicated operating model for biotechs, we’ve refined our approach to reflect the best practices we’ve learned working with small and mid-sized biotech clients as well as large pharmaceutical companies.

That’s what makes us a global CRO you can trust. You’re putting everything on the line, and our insights lead to the reliable timelines and operational excellence you need to get results.

At Parexel Biotech, performance is powered by people.

Our commercial strategists help prioritize portfolios, guide your investment opportunities, and deliver winning strategies for better outcomes.

The team includes many former regulators, HTA professionals, and industry experts, who see the unseen solutions — anticipating challenges before they arise and de-risking your development.

From Phase I first-in-human trials through to Phase IV, we use our vast experience to bring you and your patients closer to better outcomes.

And we partner with patients in trial design and delivery to help make clinical research a care option for anyone, anywhere.

From regulatory and commercial strategy to leading-edge trial design and execution, we provide the precise services you need through a configurable operating model — personalized to your project, no matter the size or scale.

That includes matching your unique requirements with an experienced, dedicated team who’ll advise, guide, and communicate with you at every step.

These experts’ passion, insights, and mastery fuel their ability to see the unseen obstacles and build smart solutions to simplify your development.

And their expertise is further amplified… by the scalable and agile global resources you’ll only find within a large CRO, that offers a unique operating model and customer experience for biotech.

When you partner with Parexel Biotech, we’ll work as one equally committed team to speed your innovation to the patients who need it most.

Because everything we do, we do with heart.

Accelerate development with Parexel Biotech

%
shorter cycle time for site initiation (faster than industry average)

(Source KMR Benchmarking Report 2023)

%
shorter cycle time from protocol approval to clinical trial report (faster than industry average)

(Source KMR Benchmarking Report 2023)

Advantages

An experienced team that’s collaborative and accountable

Leveraging our dedicated biotech operations group, we match your unique requirements with an experienced team that anticipates and adaptively delivers the solutions you need. We'll work closely with you to amplify your capabilities, but we’re also accountable, taking it upon ourselves to solve problems and seize opportunities as soon as they arise.


Patient-focused development

We’re passionate about the patients you serve — and your trial’s success is dependent upon them. That’s why we strive to improve clinical trial diversity and partner with patients to help shape protocols, reduce trial burden, and increase retention. By gathering input from patients, caregivers, and investigative site staff worldwide, we’re able to develop the most efficient, empathetic path forward.


Global execution, local expertise

No matter where you’re conducting research, we have the global reach and expertise to help you navigate competitive, regulatory, and reimbursement landscapes in all major markets, including full capabilities in China. We deliver clinical development programs worldwide to rapidly find the patients waiting for your treatment.


Early commercial planning for the most success

We’ll help you start commercial planning early to set up a clear path to investment and revenue and avoid unnecessary delays. This includes weeding out unpromising product candidates to mitigate risk and focusing on products with the best chances of success. We’ll also help you clearly articulate a coherent product value story, from start to finish, so it’s easier to raise funds, make smarter development choices, gain market share, win reimbursement, and accelerate commercialization.


 

Leading Insights

Podcast

Leveraging people, processes and technology to deliver for biotech

Oct 1, 2024

Podcast

De-risking Drug Development | Episode 5: Expand the use and value of your product over time

Sep 25, 2024

Podcast

De-risking Drug Development | Episode 4: Implement market launch strategy, pre-approval

Sep 25, 2024

Webinar

Challenges and best practices for developing Antibody-Drug Conjugates

Sep 25, 2024

Whitepaper

Biotech Innovation: Linking real-world data and patient insights to help demonstrate asset value

Aug 7, 2024

Video

How to de-risk drug development from the earliest stages

Jul 23, 2024

Podcast

De-risking Drug Development | Episode 3: Plan how to get to market quickly, post proof-of-concept

Jul 16, 2024

Podcast

Enabling Successful Sites, Ep3: Taking the complexity out of oncology clinical trials

Jun 28, 2024

Podcast

Enabling Successful Sites, Ep2: Empowering Sites to be More Inclusive Through Cultural Sensitivity Training

Jun 28, 2024

Podcast

De-risking Drug Development | Episode 2: Focus on safety and efficacy and prove quickly that your product works

Jun 19, 2024

Podcast

De-risking Drug Development | Episode 1: How to drive value in pre-clinical development

May 28, 2024

Playbook

Early-phase development strategies for navigating regulatory complexity in the EU

Apr 29, 2024

Blog

Scientific Advances: Catalyst for Biotech Investment and Innovation in Clinical Development

Mar 12, 2024

Article

Near-term strategies for biotech drug developers facing shifting healthcare dynamics

Feb 14, 2024

Playbook

What emerging trends in the FDA’s most coveted designations might tell us

Feb 8, 2024

Webinar

Assessing appropriate use of ECAs in clinical trials

May 28, 2023

Webinar

Adaptive strategies for more efficient, data-rich and patient-friendly trials

May 28, 2023

Playbook

Insights from the 2022 R&D Innovation Survey

Feb 17, 2023

Article

8 things you need to know about eCTDs in China

Jul 1, 2022

Leading Insights

Podcast

Leveraging people, processes and technology to deliver for biotech

Oct 1, 2024

Podcast

De-risking Drug Development | Episode 5: Expand the use and value of your product over time

Sep 25, 2024

Podcast

De-risking Drug Development | Episode 4: Implement market launch strategy, pre-approval

Sep 25, 2024

Webinar

Challenges and best practices for developing Antibody-Drug Conjugates

Sep 25, 2024

Whitepaper

Biotech Innovation: Linking real-world data and patient insights to help demonstrate asset value

Aug 7, 2024

Video

How to de-risk drug development from the earliest stages

Jul 23, 2024

Podcast

De-risking Drug Development | Episode 3: Plan how to get to market quickly, post proof-of-concept

Jul 16, 2024

Podcast

Enabling Successful Sites, Ep3: Taking the complexity out of oncology clinical trials

Jun 28, 2024

Podcast

Enabling Successful Sites, Ep2: Empowering Sites to be More Inclusive Through Cultural Sensitivity Training

Jun 28, 2024

Podcast

De-risking Drug Development | Episode 2: Focus on safety and efficacy and prove quickly that your product works

Jun 19, 2024

Podcast

De-risking Drug Development | Episode 1: How to drive value in pre-clinical development

May 28, 2024

Playbook

Early-phase development strategies for navigating regulatory complexity in the EU

Apr 29, 2024

Blog

Scientific Advances: Catalyst for Biotech Investment and Innovation in Clinical Development

Mar 12, 2024

Article

Near-term strategies for biotech drug developers facing shifting healthcare dynamics

Feb 14, 2024

Playbook

What emerging trends in the FDA’s most coveted designations might tell us

Feb 8, 2024

Webinar

Assessing appropriate use of ECAs in clinical trials

May 28, 2023

Webinar

Adaptive strategies for more efficient, data-rich and patient-friendly trials

May 28, 2023

Playbook

Insights from the 2022 R&D Innovation Survey

Feb 17, 2023

Article

8 things you need to know about eCTDs in China

Jul 1, 2022

Show more


CASE STUDY

Delivering two rescue studies for a small biotech

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Requirements

  • Parexel stepped in to assist a small biotech company with two vital studies on a demanding schedule.
  • The incumbent, a smaller CRO, lacked the full expertise to meet the demands of these large, complex studies.
  • Global enrollment was already well underway for both. 
  • With tight timelines for regulatory submissions in jeopardy, the sponsor concluded that Parexel would be a better fit to deliver the solutions required. 
     

Solution

  • Parexel collaborated effectively with the outgoing incumbent to make the transition.
  • With support of the Parexel executive leadership team, functional groups pulled together across the organization.
  • The solution followed these key steps: 
    • Creating a transition plan before undertaking any activities
    • Crafting a detailed project plan mapping major milestones
    • Engaging regulatory and technology teams early in the process
       

Results

  • Parexel succeeded in delivering both studies within three months without missing a single patient visit, achieving all of the sponsor’s goals.
  • Parexel was consequently awarded additional contracts, including a pediatric study, a Drug-Drug Interaction (DDI) study in breast cancer patients, biostats, medical coding, and regulatory projects. 

Winning strategies, with real results